product is used to treat moderate to moderately severe pain. It contains
2 medications: tramadol and acetaminophen. Tramadol is
similar to opioid (narcotic) analgesics. It works in the brain to
change how your body feels and responds to pain. Acetaminophen is
used to relieve pain, and it can also reduce a fever.
Nausea, vomiting, constipation, lightheadedness, dizziness,
drowsiness, or sweating may occur. Some of these side effects may
decrease after you have been using this medication for a while. If
any of these effects persist or worsen, tell your doctor or pharmacist promptly.
constipation, eat dietary fiber, drink enough water, and exercise.
You may also need to take a laxative. Ask your pharmacist which type
of laxative is right for you.
reduce the risk of dizziness and lightheadedness, get up slowly when
rising from a sitting or lying position.
that your doctor has prescribed this medication because he or she has judged
that the benefit to you is greater than the risk of side effects. Many people
using this medication do not have serious side effects.
your doctor right away if you have any serious side effects, including:
interrupted breathing during sleep (sleep apnea), mental/mood changes
(such as agitation, hallucinations), severe stomach/abdominal pain,
difficulty urinating, signs of your adrenal glands not working well
(such as loss of appetite, unusual tiredness, weight loss).
medical help right away if you have any very serious side effects, including:
fast/irregular heartbeat, severe dizziness, fainting, seizure.
medication may increase serotonin and rarely cause a very serious condition
called serotonin syndrome/toxicity. The risk increases if you are also
taking other drugs that increase serotonin, so tell your doctor or pharmacist
of all the drugs you take (see Drug Interactions section). Get
medical help right away if you develop some of the following symptoms: fast
heartbeat, hallucinations, loss of coordination, severe dizziness, severe
nausea/vomiting/diarrhea, twitching muscles, unexplained fever,
changed into a strong opioid drug in your body. In some people, this
change happens faster and more completely than usual, which increases the risk
of very serious side effects. Get medical help right away if you notice any of
the following: slow/shallow breathing, severe drowsiness/difficulty waking up,
very serious allergic reaction to this drug is rare. However, get
medical help right away if you notice any of the following symptoms: rash, itching/swelling
(especially of the face/tongue/throat), severe dizziness, trouble
is not a complete list of possible side effects. If you notice other effects
not listed above, contact your doctor or pharmacist.
taking this product, tell your doctor or pharmacist if you are
allergic to tramadol or acetaminophen; or if you have any
other allergies. This product may contain inactive ingredients, which can
cause allergic reactions or other problems. Talk to your pharmacist for more
using this medication, tell your doctor or pharmacist your medical
history, especially of: brain disorders (such as head injury,
tumor, seizures), breathing problems (such as asthma, sleep
apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver
disease, mental/mood disorders (such as confusion, depression, suicidal
thoughts), personal or family history of a substance use disorder
(such as overuse of or addiction to drugs/alcohol), stomach/intestinal
problems (such as blockage, constipation, diarrhea due to
infection, paralytic ileus), difficulty urinating (such as due to enlarged
prostate), gallbladder disease, disease of the pancreas (pancreatitis), obesity.
drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis)
can make you more dizzy or drowsy. Do not drive, use machinery, or do anything
that needs alertness until you can do it safely. Avoid alcoholic beverages.
Talk to your doctor if you are using marijuana (cannabis).
cause a condition that affects the heart rhythm (QT prolongation). QT
prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat
and other symptoms (such as severe dizziness, fainting) that need
medical attention right away.
risk of QT prolongation may be increased if you have certain medical conditions
or are taking other drugs that may cause QT prolongation. Before using
tramadol/acetaminophen, tell your doctor or pharmacist of all the drugs you
take and if you have any of the following conditions: certain heart problems
(heart failure, slow heartbeat, QT prolongation in the EKG), family
history of certain heart problems (QT prolongation in the EKG, sudden
levels of potassium or magnesium in the blood may
also increase your risk of QT prolongation. This risk may increase if you use
certain drugs (such as diuretics/"water pills") or if you have
conditions such as severe sweating, diarrhea, or vomiting. Talk
to your doctor about using tramadol/acetaminophen safely.
having surgery, tell your doctor or dentist about all the products
you use (including prescription drugs, nonprescription drugs, and herbal
children may be more sensitive to very serious side effects of tramadol, such
as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also
adults may be more sensitive to the side effects of this drug, especially
confusion, dizziness, drowsiness, slow/shallow breathing, and QT prolongation
this medication should be used only when clearly needed. It may harm an unborn
baby. Discuss the risks and benefits with your doctor. (See also Warning
medication passes into breast milk and may have undesirable effects
on a nursing infant, such as unusual sleepiness, difficulty feeding,
or trouble breathing. Breast-feeding while using this drug is not
recommended. Consult your doctor before breast-feeding.